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NCT01600586 · ClinicalTrials.gov registry record · NA
A Clinical Trial of A Pacifier-Activated Music Player
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01600586: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT01600586 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01600586, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and decreased length of hospitalization. The investigators propose to test the hypothesis that a week-long PAL intervention can improve feeding skills and decrease stress compared to standard of care parental interactions in infants in the late preterm period. The investigators also hypothesize that these improvements will result in shorter hospital stays and increased growth in the intervention group. Our study design is a prospective randomized controlled trial design of 94 infants (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will receive a book library with one lullaby book and record her voice to the PAL, which the music therapist will then administer in 15-minute sessions for 5 consecutive days. The 47 participants in the control group will receive the same library but no recording will be made or PAL used. Outcomes measured will include time to full oral feeds, suck rate and efficiency, salivary cortisol levels before and after intervention, daily growth parameters and nutritional data, and hospital length of stay.
Primary Outcome
Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention
Interventions
- DEVICE Pacifier-Activated-Lullaby system (PAL).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01600586 record still lists
NCT01600586 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Pacifier-Activated-Lullaby system (PAL). is the first listed.
NCT01600586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01600586 about?
NCT01600586 is a clinical study titled "A Clinical Trial of A Pacifier-Activated Music Player". Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifie...
What is the current status of trial NCT01600586?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2012-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01600586?
The interventions under investigation include: Pacifier-Activated-Lullaby system (PAL). (DEVICE).
Who is sponsoring clinical trial NCT01600586?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01600586's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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